Rationale and design of the beta-blocker in heart failure with normal left ventricular ejection fraction (beta-PRESERVE) study

Abstract

Aims: Chronic heart failure with normal left ventricular ejection fraction (HFNEF) is not only common, but also carries a high risk of substantial morbidity and mortality. However, few studies have been conducted in this population and no proven treatment is available. Although beta-blockers are evidence-based first-line therapy in systolic heart failure, they have not been well studied in HFNEF.

Methods: This study is a multicentre, prospective, randomized, open-label, blinded endpoint (PROBE) trial. A total of 1200 patients will be randomized to either beta-blocker (metoprolol succinate) or control (n = 600 per group). The primary endpoint is a composite of hospitalization for heart failure and cardiovascular death. The secondary endpoints include cardiovascular death, heart failure mortality or hospitalization, all-cause mortality, change in New York Heart Association class, change in left ventricular ejection fraction, increase in NT-proBNP (by > or = 50% of the value at randomization), beta-blocker tolerance, and premature termination of beta-blocker therapy due to adverse events. The follow-up period is a minimum of 2 years.

Conclusion: This study will provide important evidence, for the first time to our knowledge, of the long-term efficacy of beta-blocker therapy in the management of HFNEF.